About this trial
In Denmark, 12,000 people experience a stroke every year. It is the fourth largest cause of death, and costs 4,6 billion Danish crowns in healthcare expenses and lost work income. It is also the leading cause of acquired disability for adults. Pre-hospital recognition of stroke is paramount to ensure fast and correct treatment for patients, in turn leading to better outcomes for patients. As the advanced treatment for ischemic stroke, thrombolysis and thrombectomy, is time-sensitive, even short delays in recognition and treatment can have a large effect on the individual stroke patient.
Paramedics on scene have only a few tools to assist them in recognizing stroke, where clinical scales such as the National Institutes of Health Stroke Scale (NIHSS), Face Arm Speech Time (FAST) or Prehospital Stroke Score (PRESS ) are most commonly used. Despite the use of such instruments, patients with stroke still go unrecognized, and as a result, the unrecognized patient might not be hospitalized, be hospitalized in a hospital without stroke facilities or be hospitalized too late for advanced treatment. Lower quality of communication between paramedics and the stroke centre significantly increases prehospital on-scene time. In a consensus statement from the European Academy of Neurology (EAN) and the European Stroke Organisation (ESO), training paramedics to recognise symptoms of all stroke types was strongly recommended. This study aims to explore whether trained paramedics using a mobile application with NIHSS and video communication to the in-hospital stroke physician may improve triage of acute stroke patients. This intervention will be compared to paramedics using standard procedure and communication through regular channels. It is hypothesized that the number of patients brought to the emergency department with suspected acute stroke and discharged with a stroke diagnosis is significantly higher in the app-group (intervention) compared to standard prehospital model (control).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A. Suspected stroke by paramedic or dispatcher
Disqualifiers
Technical issues (ie. the telephone does not work, the app does not work).
Patients who are incarcerated
Patients seen by a physician prior to assessment by paramedics.
Subarachnoid Haemorrhage strokes
Trial design
Sequential
Treatments tested in this trial
CV_AID
DeviceUpon arrival at the scene, the paramedic utilizes a mobile app with an integrated camera to aid in conducting the National Institutes of Health Stroke Scale (NIHSS) assessment. The app assists in scoring the patient\'s responses according to NIHSS criteria to determine the severity of stroke symptoms. If the app assessment indicates a high likelihood of stroke, transport can be initiated without a conference with the neurovascular centre. The app shares the recorded NIHSS assessment and video of the patient with the neurovascular centre for review. While en route, the paramedic confer with the neurovascular centre to discuss the patient\'s condition and determine appropriate course of action. If the neurovascular centre decides not to treat the patient, transport can be diverted to the nearest hospital. The paramedic documents all assessment findings, interventions, and communications related to the stroke patient in the patient care record. U
Treatment groups
Trial outcomes
Primary outcomes
Prehospital recognition of stroke
The primary outcome will be prehospital recognition of stroke by paramedics, quantified as the proportion of patients discharged with a final stroke diagnosis who are accepted for stroke evaluation by the neurologist at the neurovascular centre.
Secondary outcomes
Time on scene
Time spent on-scene is a key metric for the evaluation of prehospital health services. Less time spent on scene is directly correlated with time to hospital admittance, presuming correct triage of the patient. As this study introduces a potential delaying factor in the use of an app and the performance of a full NIHSS evaluation, this metric is key to evaluating whether this new initiative is a net positive for patients with stroke.
Door-to-scanner time
Investigators theorise that the availability of a reliable NIHSS score as well as the video material from the evaluation of the patient will enable the neurologist at the neurovascular centre to make faster assessment, which could lead to reduced door-to-scanner times.
Change in 90-day neurological outcome measured by the modified rankin scale (mRS)
The 90-day neurological outcome is important, as this outcome reflects the degree of disability experienced by the patient, and thereby the recovery from stroke. If this study leads to faster and more accurate diagnoses and treatment, investigators to see this reflected in the 90 day-neurological outcome. Neurological outcome is measured by the modified rankin scale (mRS), a clinical scale to measure the degree of disability or dependence in daily activities of people who have had a stroke or other neurological diseases. It ranges from 0 (no symptoms) to 6 (death). The mRS is the standard scale for evaluating the patients degree of disability post-stroke, and is available as part of the DanStroke registry data for all patients.
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